The FDA and electroconvulsive therapy

Last week an advisory panel of the United States’ Food and Drug Administration (FDA) voted to keep electroconvulsive therapy devices in class III, the high-risk category which will require them to undergo further testing for safety and efficacy. This is the latest step in a saga that has being going on since 1976, when the FDA was given authority to classify medical devices as high, medium, or low risk. ECT machines were put into the high risk category. The American Psychiatric Association has been campaigning ever since to have them put into a lower risk category; patient groups want them to remain in the high risk category. In the meantime the testing for safety and efficacy normally required of high-risk devices has been put on hold. But in 2009 the Government Accountability Office asked the FDA to do something about ECT machines and either reclassify them as lower risk or demand testing from the manufacturers. So at the end of January the FDA’s Neurological Devices Advisory Committee met for 2 days to discuss the matter. You can read more about the background in this article from the New York Times, while the outcome of the meeting is discussed in this one. The FDA’s summary of the two-day meeting can be read here.

The panel voted by a majority of one (the chair having the deciding vote) to classify ECT machines as high risk in the treatment of depression. The FDA is not obliged to act on the panel’s recommendations although apparently it usually does. Depression is the disorder for which ECT is most often used in the USA, and the UK and other Western countries. For the treatment of schizophrenia the vote was 13-4 for putting ECT machines in the high risk category. It was only in the treatment of catatonia that the panel recommended reclassifying ECT machines as Class II (lower risk than Class III), the reasoning being that there is a lack alternative treatments for catatonia. Peter Breggin, in an article in the Huffington Post, criticized this loophole and pointed out that “It is scientifically unsound to act as though ECT causes serious safety risks with one disorder but not another”. But overall the panel’s decisions have been cautiously welcomed by patient groups who have for many years been campaigning to prevent the FDA reclassifying ECT machines into a lower risk category.

While the FDA advisory panel were voting 13 to 4 to classify the use of ECT in schizophrenia as a high risk procedure, Guy Fessenden was running coast to coast to raise money for various organizations involved with research into mental illness. He was inspired by his daughter’s experience with ECT, which didn’t help her and left her with memory problems. He was quoted as saying that the money raised “goes to help people like my daughter so they don’t have to use things like ECT which was invented in the 1930s. What other form of illness do we have where the leading technology is 80 years old? This may be the best technology available, but it is horrible”.

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One Response to The FDA and electroconvulsive therapy

  1. Cheryl Prax says:

    Good summary. Thanks for the FDA summary link – I hadn’t seen that. I will definitely get the transcripts.
    Have you seen the Washington Post’s review of the meeting?

    I saw the article about Guy Fessenden. I must make a comment on his site. He is looking for donations but I wonder whether the organisation he is funding are just looking for drug solutions which is not good. It is so sad that his daughter is now permanently damaged from ECT. Drugs can cause damage too but ECT is ‘deadly’ as indeed the first (non consenting) victim exclaimed.

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